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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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Purpose of this study:
To establish the superiority of myomectomy versus Uterine Artery Embolization, in women with multiple symptomatic fibroids and no other infertility factor, seeking to conceive.
Background:
The use of uterine artery embolization (UAE) to treat symptomatic fibroids in women seeking future fertility remains a matter of debate, because of possible adverse effects on ovarian reserve and embryo implantation. In women with associated infertility factors, not eligible for myomectomy, poor fertility was obtained after UAE. On the other hand, fertility of women eligible for surgical myomectomy, deciding to have a UAE, compares favourably with the fertility obtained after myomectomy.
Study design:
Eligible women will be explored to pull out any other infertility factors such as:
Women will be treated with fertility sparing ultra selective uterine artery embolization, or surgical removal of multiple myomas.
A six months convalescence/cicatrisation period will be respected, then women will be allowed to intend to conceive.
Several elements will be prospectively followed:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| myomectomy | Active Comparator | Women will be treated with surgical removal of all fibroids, either by laparoscopic or abdominal route |
|
| embolisation | Experimental | Women will be treated with fertility sparing uterine arteries embolization (i..e. with ultra thin catheter, and particles' diameter > 500µm) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| myomectomy | Procedure | Surgical ablation of all fibroids |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of live birth in a year of fertility attempt | Women will be allowed to attempt fertility 6 months after treatment. Effective fertility attempts will be prospectively followed. Final fertility will be assessed one year later. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| number of adverse effects on fertility (ovarian reserve markers) | 18 months | |
| number of adverse effects on fertility (state of the uterine cavity) | 18 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antoine Torre, MD, PhD | Faculté de médecine de Montpellier-Nîmes, Université de Montpellier 1, France. | Principal Investigator |
| Arnaud Fauconnier, MD, PhD | UFR des sciences de la santé Simone Veil, Université de Versailles Saint Quentin en Yvelines, France. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Département de Médecine de la Reproduction, Centre Hospitalier Régionnal Universitaire de Montpellier | Montpellier | 34000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22592701 | Background | Gupta JK, Sinha A, Lumsden MA, Hickey M. Uterine artery embolization for symptomatic uterine fibroids. Cochrane Database Syst Rev. 2012 May 16;(5):CD005073. doi: 10.1002/14651858.CD005073.pub3. | |
| 24430777 | Background | Torre A, Paillusson B, Fain V, Labauge P, Pelage JP, Fauconnier A. Uterine artery embolization for severe symptomatic fibroids: effects on fertility and symptoms. Hum Reprod. 2014 Mar;29(3):490-501. doi: 10.1093/humrep/det459. Epub 2014 Jan 15. |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D063186 | Uterine Myomectomy |
| D004621 | Embolization, Therapeutic |
| ID | Term |
|---|---|
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D006489 | Hemostatic Techniques |
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| embolisation |
| Procedure |
Embolisation of the peri-myoma vascular network, with non-resorbable particles of >500 µm diameter, using an ultra thin catheter introduced through the vascular network up to the uterine arteries under radioscopic control. |
|
|
| number of adverse effects on fertility (state of the endometrium |
| 18 months |
| Improvement of symptoms related to fibroids With UFS-QoL questionnaires | 3 months |
| Improvement of symptoms related to fibroids With UFS-QoL questionnaires | 6 months |
| Improvement of symptoms related to fibroids With UFS-QoL questionnaires | 12 months |
| Improvement of symptoms related to fibroids With UFS-QoL questionnaires | 18 months |
| Quality of life With QSF questionnaires, a French version of the WHQ questionnaire | 3 months |
| Quality of life With QSF questionnaires, a French version of the WHQ questionnaire | 6 months |
| Quality of life With QSF questionnaires, a French version of the WHQ questionnaire | 12 months |
| Quality of life With QSF questionnaires, a French version of the WHQ questionnaire | 18 months |
| Number of adverse effects during pregnancy : Rate of Miscarriage | Until 30 months |
| Number of adverse effects during pregnancy : extra-uterine pregnancy | until 24 months |
| Number of adverse effects during pregnancy : small for gestational age | Until 30 months |
| Number of adverse effects during pregnancy : foetal death | Until 30 months |
| Number of adverse effects during pregnancy : uterine rupture | Until 30 months |
| Number of adverse effects during pregnancy : abnormal placental position and implantation | Until 30 months |
| Number of adverse effects during pregnancy : preterm delivery | Until 29 months |
| Number of adverse effects during pregnancy : delivery hemorrhagy | Until 30 months |
| number of adverse effects in the newborn | Rate of small for gestational age, delivery presentation, health of newborn children (Apgar score, cord pH, admission in the neonatology service) | At day 3 of life |
| 17943348 | Background | Mara M, Maskova J, Fucikova Z, Kuzel D, Belsan T, Sosna O. Midterm clinical and first reproductive results of a randomized controlled trial comparing uterine fibroid embolization and myomectomy. Cardiovasc Intervent Radiol. 2008 Jan-Feb;31(1):73-85. doi: 10.1007/s00270-007-9195-2. Epub 2007 Oct 18. |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |